EP2136839A4 - STABLE ANTIBODY FORMULATIONS - Google Patents

STABLE ANTIBODY FORMULATIONS

Info

Publication number
EP2136839A4
EP2136839A4 EP08744136A EP08744136A EP2136839A4 EP 2136839 A4 EP2136839 A4 EP 2136839A4 EP 08744136 A EP08744136 A EP 08744136A EP 08744136 A EP08744136 A EP 08744136A EP 2136839 A4 EP2136839 A4 EP 2136839A4
Authority
EP
European Patent Office
Prior art keywords
antibody formulations
stable antibody
stable
formulations
antibody
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP08744136A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP2136839A2 (en
Inventor
Arvind Srivastava
Joel Goldstein
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
ImClone LLC
Original Assignee
ImClone LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by ImClone LLC filed Critical ImClone LLC
Publication of EP2136839A2 publication Critical patent/EP2136839A2/en
Publication of EP2136839A4 publication Critical patent/EP2136839A4/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
EP08744136A 2007-03-22 2008-03-20 STABLE ANTIBODY FORMULATIONS Withdrawn EP2136839A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US91974407P 2007-03-22 2007-03-22
PCT/US2008/057718 WO2008116103A2 (en) 2007-03-22 2008-03-20 Stable antibody formulations

Publications (2)

Publication Number Publication Date
EP2136839A2 EP2136839A2 (en) 2009-12-30
EP2136839A4 true EP2136839A4 (en) 2010-04-07

Family

ID=39766776

Family Applications (1)

Application Number Title Priority Date Filing Date
EP08744136A Withdrawn EP2136839A4 (en) 2007-03-22 2008-03-20 STABLE ANTIBODY FORMULATIONS

Country Status (18)

Country Link
US (1) US20100260766A1 (ru)
EP (1) EP2136839A4 (ru)
JP (1) JP2010522208A (ru)
KR (1) KR20090113340A (ru)
CN (1) CN101668540A (ru)
AU (1) AU2008228823A1 (ru)
BR (1) BRPI0809112A2 (ru)
CA (1) CA2681743A1 (ru)
CR (1) CR11005A (ru)
DO (1) DOP2009000222A (ru)
EA (1) EA200970880A1 (ru)
EC (1) ECSP099642A (ru)
IL (1) IL200321A0 (ru)
MX (1) MX2009010179A (ru)
TN (1) TN2009000382A1 (ru)
UA (1) UA96473C2 (ru)
WO (1) WO2008116103A2 (ru)
ZA (1) ZA200905636B (ru)

Families Citing this family (35)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160279239A1 (en) 2011-05-02 2016-09-29 Immunomedics, Inc. Subcutaneous administration of anti-cd74 antibody for systemic lupus erythematosus and autoimmune disease
US20160355591A1 (en) 2011-05-02 2016-12-08 Immunomedics, Inc. Subcutaneous anti-hla-dr monoclonal antibody for treatment of hematologic malignancies
TW200838559A (en) * 2006-11-29 2008-10-01 Imclone Systems Inc Insulin-like growth factor-1 receptor antagonists for modulation of weight and liposity
PE20090368A1 (es) 2007-06-19 2009-04-28 Boehringer Ingelheim Int Anticuerpos anti-igf
WO2010056550A1 (en) 2008-10-29 2010-05-20 Wyeth Llc Methods for purification of single domain antigen binding molecules
CN102271707B (zh) 2008-10-29 2015-04-08 阿布林克斯公司 单域抗原结合性分子的制剂
US20110293605A1 (en) * 2008-11-12 2011-12-01 Hasige Sathish Antibody formulation
EP2196476A1 (en) * 2008-12-10 2010-06-16 Novartis Ag Antibody formulation
UY32317A (es) 2008-12-12 2010-07-30 Boehringer Ingelheim Int Anticuerpos anti-igf
AR080428A1 (es) 2010-01-20 2012-04-11 Chugai Pharmaceutical Co Ltd Formulaciones liquidas estabilizadas contentivas de anticuerpos
WO2012028683A1 (en) 2010-09-02 2012-03-08 Novartis Ag Antibody gel system for sustained drug delivery
SG188487A1 (en) 2010-09-17 2013-05-31 Baxter Int Stabilization of immunoglobulins through aqueous formulation with histidine at weak acidic to neutral ph
KR20180129991A (ko) 2010-11-05 2018-12-05 노파르티스 아게 Ｉｌ-１７ 길항제를 사용한 류마티스성 관절염의 치료 방법
WO2012151199A1 (en) 2011-05-02 2012-11-08 Immunomedics, Inc. Ultrafiltration concentration of allotype selected antibodies for small-volume administration
KR102091294B1 (ko) * 2011-10-26 2020-04-16 암젠 인크 Uv 광으로의 노출로 인한 단백질 변형 및 분해의 감소 또는 제거 방법
JP5775974B2 (ja) 2011-10-28 2015-09-09 プロセナ バイオサイエンシーズ リミテッド アルファシヌクレインを認識するヒト化抗体
WO2013112945A1 (en) 2012-01-27 2013-08-01 Neotope Biosciences Limited Humanized antibodies that recognize alpha-synuclein
AR091902A1 (es) * 2012-07-25 2015-03-11 Hanmi Pharm Ind Co Ltd Formulacion liquida de un conjugado de insulina de accion prolongada
AR092862A1 (es) * 2012-07-25 2015-05-06 Hanmi Pharm Ind Co Ltd Formulacion liquida de insulina de accion prolongada y un peptido insulinotropico y metodo de preparacion
AR094821A1 (es) * 2012-07-25 2015-09-02 Hanmi Pharm Ind Co Ltd Formulación líquida de un conjugado de péptido insulinotrópico de acción prolongada
UA118441C2 (uk) 2012-10-08 2019-01-25 Протена Біосаєнсиз Лімітед Антитіло, що розпізнає альфа-синуклеїн
JP2016505601A (ja) 2012-12-26 2016-02-25 ウォックハート リミテッド 医薬組成物
US20140255413A1 (en) 2013-03-07 2014-09-11 Boehringer Ingelheim International Gmbh Combination therapy for neoplasia treatment
US9700485B2 (en) 2013-04-24 2017-07-11 Corning Incorporated Delamination resistant pharmaceutical glass containers containing active pharmaceutical ingredients
NL1040254C2 (en) * 2013-05-17 2014-11-24 Ablynx Nv Stable formulations of immunoglobulin single variable domains and uses thereof.
US10513555B2 (en) * 2013-07-04 2019-12-24 Prothena Biosciences Limited Antibody formulations and methods
US9732154B2 (en) 2014-02-28 2017-08-15 Janssen Biotech, Inc. Anti-CD38 antibodies for treatment of acute lymphoblastic leukemia
EP3129051A1 (en) 2014-04-08 2017-02-15 Prothena Biosciences Limited Blood-brain barrier shuttles containing antibodies recognizing alpha-synuclein
AR104847A1 (es) * 2015-06-17 2017-08-16 Lilly Co Eli Formulación de anticuerpo anti-cgrp
US20170044265A1 (en) 2015-06-24 2017-02-16 Janssen Biotech, Inc. Immune Modulation and Treatment of Solid Tumors with Antibodies that Specifically Bind CD38
EA202190808A2 (ru) 2015-11-03 2021-12-31 Янссен Байотек, Инк. Составы антител к cd38 для подкожного введения и их применение
JP6992262B2 (ja) * 2016-03-31 2022-02-15 東ソー株式会社 変性抗体測定試薬の製造方法
EP3606964A4 (en) 2017-04-03 2020-12-09 Immunomedics, Inc. SUBCUTANE ADMINISTRATION OF ANTIBODY DRUG CONJUGATES FOR CANCER THERAPY
MA50514A (fr) 2017-10-31 2020-09-09 Janssen Biotech Inc Méthodes de traitement du myélome multiple à haut risque
MX2021009851A (es) 2019-02-18 2021-09-10 Lilly Co Eli Formulacion de anticuerpos terapeuticos.

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992022653A1 (en) * 1991-06-14 1992-12-23 Genentech, Inc. Method for making humanized antibodies
US20020045571A1 (en) * 2000-10-12 2002-04-18 Genentech, Inc. Reduced-viscosity concentrated protein formulations
WO2003009817A2 (en) * 2001-07-25 2003-02-06 Protein Design Labs, Inc. Stable lyophilized pharmaceutical formulation of igg antibodies
WO2005005635A2 (en) * 2003-07-10 2005-01-20 F. Hoffmann-La Roche Ag Antibodies against insulin-like growth factor i receptor and uses thereof
US20050069539A1 (en) * 2003-08-13 2005-03-31 Pfizer Inc Modified human IGF-IR antibodies
US20060286103A1 (en) * 2005-06-15 2006-12-21 Parag Kolhe Stable antibody formulation
WO2007110339A1 (en) * 2006-03-28 2007-10-04 F. Hoffmann-La Roche Ag Anti-igf-1r human monoclonal antibody formulation

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0565233A (ja) * 1991-03-08 1993-03-19 Mitsui Toatsu Chem Inc モノクローナル抗体含有凍結乾燥製剤
US6267958B1 (en) * 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
CA2451955C (en) * 2001-06-26 2015-09-29 Abgenix, Inc. Antibodies to opgl
KR101080021B1 (ko) * 2002-02-14 2011-11-04 추가이 세이야쿠 가부시키가이샤 항체함유 용액제제
MXPA05008617A (es) * 2003-02-13 2005-11-04 Pfizer Prod Inc Usos de anticuerpos anti-receptor del factor de crecimiento semejante a la insulina i.
EP1622942B1 (en) * 2003-05-01 2014-11-19 ImClone LLC Fully human antibodies directed against the human insulin-like growth factor-1 receptor
MX2007014148A (es) * 2005-05-19 2008-01-11 Amgen Inc Composiciones y metodos para incrementar la estabilidad de anticuerpos.

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992022653A1 (en) * 1991-06-14 1992-12-23 Genentech, Inc. Method for making humanized antibodies
US20020045571A1 (en) * 2000-10-12 2002-04-18 Genentech, Inc. Reduced-viscosity concentrated protein formulations
WO2003009817A2 (en) * 2001-07-25 2003-02-06 Protein Design Labs, Inc. Stable lyophilized pharmaceutical formulation of igg antibodies
WO2005005635A2 (en) * 2003-07-10 2005-01-20 F. Hoffmann-La Roche Ag Antibodies against insulin-like growth factor i receptor and uses thereof
US20050069539A1 (en) * 2003-08-13 2005-03-31 Pfizer Inc Modified human IGF-IR antibodies
US20060286103A1 (en) * 2005-06-15 2006-12-21 Parag Kolhe Stable antibody formulation
WO2007110339A1 (en) * 2006-03-28 2007-10-04 F. Hoffmann-La Roche Ag Anti-igf-1r human monoclonal antibody formulation

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
PRESTA L ET AL: "Humanization of an antibody directed against IgE", JOURNAL OF IMMUNOLOGY, AMERICAN ASSOCIATION OF IMMUNOLOGISTS, US, vol. 151, no. 5, 1 September 1993 (1993-09-01), pages 2623 - 2632, XP002094432, ISSN: 0022-1767 *

Also Published As

Publication number Publication date
DOP2009000222A (es) 2009-12-15
ECSP099642A (es) 2009-11-30
CN101668540A (zh) 2010-03-10
CR11005A (es) 2010-08-05
WO2008116103A3 (en) 2009-01-08
EP2136839A2 (en) 2009-12-30
ZA200905636B (en) 2010-10-27
UA96473C2 (ru) 2011-11-10
AU2008228823A1 (en) 2008-09-25
EA200970880A1 (ru) 2010-02-26
BRPI0809112A2 (pt) 2014-08-26
KR20090113340A (ko) 2009-10-29
TN2009000382A1 (en) 2010-12-31
WO2008116103A2 (en) 2008-09-25
JP2010522208A (ja) 2010-07-01
IL200321A0 (en) 2010-04-29
CA2681743A1 (en) 2008-09-25
MX2009010179A (es) 2010-03-15
US20100260766A1 (en) 2010-10-14

Similar Documents

Publication Publication Date Title
HUS2100038I1 (hu) Anti-CD20 antitest készítmények
HRP20182146T1 (hr) Formulacije protutijela natalizumab
IL200321A0 (en) Stable antibody formulations
HK1214947A1 (zh) 抗體製劑
EP2173163A4 (en) ANTIBODY FORMULATIONS
EP2077859A4 (en) ANTIBODY FORMULATION
SG10201604258YA (en) Anti-tnf antibody formulations
GB0711656D0 (en) Formulations
GB0716385D0 (en) Formulations
ZA200908969B (en) Formulations
GB0711957D0 (en) Formulations
GB0809979D0 (en) Formulations
GB0810232D0 (en) Formulations
EP2167635A4 (en) ANTIBODY FORMULATIONS
GB0705179D0 (en) Formulations
GB0710346D0 (en) Formulations
GB0708663D0 (en) Formulations
GB0713886D0 (en) Formulations
GB0710900D0 (en) Formulations
GB0701993D0 (en) Formulations
GB0710350D0 (en) Formulations

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20091022

AK Designated contracting states

Kind code of ref document: A2

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MT NL NO PL PT RO SE SI SK TR

AX Request for extension of the european patent

Extension state: AL BA MK RS

A4 Supplementary search report drawn up and despatched

Effective date: 20100304

REG Reference to a national code

Ref country code: HK

Ref legal event code: DE

Ref document number: 1134440

Country of ref document: HK

17Q First examination report despatched

Effective date: 20100504

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN

18D Application deemed to be withdrawn

Effective date: 20120904

REG Reference to a national code

Ref country code: HK

Ref legal event code: WD

Ref document number: 1134440

Country of ref document: HK